Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer

NCT06231771 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SGT-DFU-23-001
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs. Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.

Conditions

Diabetic Foot Ulcer

Keywords

DFU; Stem cells; Per-ulcer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with complete healing/closure of the target ulcer at any time during the 6-weeks period.

  ulcer assessment (area and photograph)

  The monitoring of ulcer healing progress will continue until week 6 after the administration of the investigational medicinal product (IMP). The primary measure of effectiveness will be evaluated during the 8th visit which will take place at week 6.

Secondary Outcomes (4)

• The proportion of patients with sustained complete closure for additional 6-weeks of follow-up.

  weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)

• Time to complete closure of target ulcer.

  weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)

• Rate of reduction in the size of the target ulcer during the 6 weeks of follow-up.

  weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)

• The proportion of patients with at least 50% closure of target ulcer during the 6-weeks period

  weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)

Study Arms (2)

Allogeneic mesenchymal stem cells (MSCs)

EXPERIMENTAL

Peri-ulcer injection of Umbilical cord MSC (1.0 million cells/cm2 of the ulcer) will be administered at multiple sites (maximum of 30 sites) with intervals of 3 cm x 3 cm around the ulcer with total volume of 0.1 to 0.2 ml per injection. Whatever IMP is drawn into the syringe for administration to the wound must be completely dispensed and nothing should be left in the syringe. Number of injections and volume of each injection can be as per Investigator's discretion. The same to be recorded in the source notes and CRF.The injection will be done approximately using a 24G needle and 1 ml/3ml syringe approximately within 0.75 cm from the edge of the ulcer. The needle should enter the base of the ulcer from the edge. After injection, patients must be in a lying down position for at least one hour in daycare center at the site and monitoring of oxygen saturation will be done up to 2 hours ± 10 minutes after the administration of the product.

Drug: Allogeneic mesenchymal stem cells (MSCs)

Normal Saline

PLACEBO COMPARATOR

The blinded placebo group will be injected with normal saline (NSand the volume to be injected is similar to the area of ulcer (2 mL of normal saline per 1 cm2 of ulcer). each injection will be o.1 to 0.2 ml normal saline (maximum injection will be 30 injection peri ulcer)

Drug: Normal Saline

Interventions

Allogeneic mesenchymal stem cells (MSCs) DRUG

Dosage · Dosing of IMP is based on ulcer size. The recommended dose is 1 million cells/cm2 of ulcer. Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)

Also known as: Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in vials consisting of 3 million cells, suspended in 1.5 ml saline.

Allogeneic mesenchymal stem cells (MSCs)

Normal Saline DRUG

Dosage · Dosing of placebo is based on ulcer size. the volume will be samed as the experimental groups which is 2 ml per 1cm2 Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)

Also known as: Placebo (Normal Saline)

Normal Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18-70 years old.
• Patients have type 2 diabetes mellitus
• Patients with HbA1c, less than or equal to 10%.
• Patients who were presented with an ulcer size between 8 to 12 cm2, have been diagnosed as full-thickness DFU.
• Adequate vascular perfusion (ABI ≥ 0.7 and \< 1.3)
• Patients who are able and willing to provide consent and agree to comply with study procedures and follow-up evaluations.

You may not qualify if:

• Patients who are not diabetic.
• Patients with 2 or more ulcers.
• Patients with a history of participating in another stem cells trial or therapy within 3 months.
• Patients who are unsuitable to participate the clinical trial as determined by Investigators.

Sponsors & Collaborators

• Supergenics Life Science Sdn. Bhd.: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Equipment and Supplies; Excipients; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Pharmaceutical Vehicles; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Mohd Yazid Bajuri

  Hospital Canselor Tunku Muhriz (HCTM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abid Nordin

CONTACT

+6012-712 2468; abid@medcentral.com.my

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dosage · Dosing of IMP is based on ulcer size. The recommended dose is 1 million cells/cm2 of ulcer. Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients) Dosage · Dosing of placebo is based on ulcer size. the volume will be same as the experimental groups which is 2 ml per 1cm2 Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: May 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03